The study, which is the first to show that a
multi-strain vaginal synbiotic can establish a protective vaginal
environment, will be presented at the Annual Meeting of the
Infectious Diseases Society for Obstetrics and Gynecology
(IDSOG)
The data demonstrate that VS-01™ successfully
cultivates a vaginal microbiome dominated by Lactobacillus
crispatus, reduces harmful microbes, and combats vaginal
dysbiosis
These results underscore the potential of the
vaginal microbiome and microbiome-directed innovations to redefine
standards of care in women's health
BOSTON, Aug. 1, 2024
/PRNewswire/ -- Seed Health will present new clinical data on its
flagship vaginal microbiome innovation, VS-01™ Vaginal Synbiotic,
at the upcoming 2024 Infectious Diseases Society for Obstetrics and
Gynecology (IDSOG) Annual Meeting. Data from a randomized,
placebo-controlled clinical trial demonstrated the superior
efficacy of VS-01™ in cultivating a stable and healthy vaginal
microbiome. The synbiotic successfully established a protective
environment dominated by Lactobacillus crispatus and
inhibited harmful microbes associated with vaginal dysbiosis and
inflammation. These findings highlight the transformative potential
of proactive, preventive care centered on the vaginal microbiome,
shifting the focus from traditional symptom management to
maintaining a balanced and resilient vaginal ecology.
A landmark 2012 study from vaginal microbiome researcher
Jacques Ravel, Ph.D., demonstrated
that the most stable and optimal vaginal microbiome is
characterized by a dominance of the bacterium Lactobacillus
crispatus, which plays a protective role in maintaining vaginal
health. However, everyday factors such as menstruation, sexual
activity, exercise, stress, contraceptives, and cleansers can
deplete the abundance of L. crispatus, leading to dysbiosis
and related gynecological, urogenital, and obstetric conditions.
Despite this, there have been no consumer innovations nor
microbiome-directed solutions clinically validated to cultivate
this optimal vaginal ecology.
"Over more than two decades of research, we have elucidated the
critical role of Lactobacillus crispatus in maintaining a
protective and stable vaginal microbiome and identified specific
strains that are particularly effective at promoting vaginal
health," explained Dr. Jacques
Ravel, lead researcher. "VS-01™ was formulated using a
consortia design with three proprietary strains of L.
crispatus to successfully establish an L.
crispatus-dominant vaginal microbiome, marking a significant
milestone in the field and advancement for women's health."
"VS-01™ was developed to set a new standard in vaginal care,"
stated Sheri Simmons, Ph.D., VP of
Discovery at Seed Health. "Our latest clinical findings underscore
the potential of proactive care centered on the vaginal microbiome.
By modulating the vaginal ecology, VS-01™ offers a new approach to
support long-term vaginal health." Dr. Simmons will lead the
presentations of two abstracts on VS-01™ at IDSOG.
IDSOG Presentation Highlights
- Oral Presentation: A Novel Multi-strain Vaginal
Synbiotic is Effective in Optimizing the Vaginal Microbiome:
Results from a Randomized, Placebo-controlled Clinical Trial
Date and Time: Thursday,
August 1 at 10:45 AM PT
This clinical trial evaluated the efficacy of VS-01™ in optimizing
the vaginal microbiome. Key findings include:
- Established an Optimal Vaginal Microbiome: 90% of
participants using VS-01™ established an optimal vaginal microbiome
dominated by L. crispatus within 21 days of use,
compared to only 11% in the placebo group (p<0.002).
- Advanced Delivery Technology: Seed's proprietary VS-01
SMART Tablet™ has an extended-release profile, which demonstrated
superior conversion to an L. crispatus-dominant vaginal
microbiome compared to all other formats: placebo, a fast-release
vaginal capsule with the same strains, an oral format with the same
strains, and a leading oral probiotic for vaginal health.
- Non-Efficacy of Oral Probiotic for Vaginal
Health: The VS-01™ suppository tablet rapidly increased
the abundance of L. crispatus in the vaginal environment. In
contrast, no strains from a leading oral probiotic for vaginal
health were detected in the vagina by the end of the study.
This study is the first to demonstrate that a multi-strain vaginal
synbiotic can establish a protective vaginal environment.
- Poster Presentation: A Novel Multi-strain Vaginal
Synbiotic is Effective in Inhibiting Microbes Associated with
Vaginal Dysbiosis, Inflammation, and Mucus Barrier Degradation
Date and Time: Friday, August
2 at 1:30 PM PT
This study assessed the impact of VS-01™ on vaginal dysbiosis,
inflammation, and mucus barrier integrity. Key findings
include:
-
- Lowered Inflammation: VS-01™ significantly reduced the
levels of the inflammatory cytokine IL-1alpha.
- Reduction in Harmful Microbes: VS-01™ demonstrated a
significant reduction in Candida spp. and
Gardnerella. Specifically, the mean abundance of Candida
spp. was significantly lower in the VS-01™ arm compared to
placebo at Day 21 (p=0.041). The abundance of
Gardnerella significantly decreased in the VS-01™ arm
from baseline to Day 21 (p=0.013).
- Inhibition of Pathogens and Pathobionts: VS-01™ reduced
levels of microbes associated with vaginal dysbiosis, suggestive of
colonization resistance.
- Decrease in Mucin-degrading Genes: Treatment with VS-01™
resulted in a notable decrease in mucin-degrading sialidase genes,
suggesting an improvement in the protective mucus barrier.
These findings suggest that VS-01™ effectively inhibits harmful
microbes and supports the vaginal mucosal barrier, fostering an
optimal and protective vaginal environment.
These presentations will detail the methodology and results from
the two clinical abstracts, underscoring the transformative
potential of microbiome science to enhance women's health and
well-being.
"The data presented at IDSOG showcases the rigorous scientific
approach we bring to probiotics and microbiome-directed solutions,"
stated Dirk Gevers, Ph.D., Chief
Scientific Officer at Seed Health. "By evaluating biomarkers of
vaginal health and conducting deep microbiome sequencing, we have
validated the clinical benefits of VS-01™ to clearly distinguish it
from other vaginal health solutions."
About Seed Health
Seed Health is a microbiome science company pioneering
innovations in probiotics and living medicines to impact human and
planetary health. Founded to realize the potential of the
microbiome, our platform enables the translation of breakthrough
science across a portfolio targeting health outcomes from infancy
to aging. Our consumer innovations are commercialized
under Seed®, an award-winning, science-first brand known for
clinically validated innovations in probiotics, including DS-01®
Daily Synbiotic and PDS-08® Pediatric Daily Synbiotic. Our pipeline
encompasses both indication-specific and preventive applications
for gastrointestinal and digestive health, women's health, skin,
pediatrics, brain health, metabolic function, and healthy aging.
Our environmental research is conducted under SeedLabs, which was
founded to advance novel bacterial interventions to enhance
biodiversity and restore ecosystems impacted by human activity.
Press Contact
press@seed.com
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SOURCE Seed Health